FDA 510(k) Application Details - K201562

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K201562
Device Name	Spirometer, Diagnostic
Applicant	Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare V95 HFT4 IE Other 510(k) Applications for this Company
Contact	Tony O'Hanlon Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2020
Decision Date	10/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review